Kornimate/medical-research-clean huggingface dataset:
effectiveness of myopia control by breath-o correct orthokeratology lenses

Conditions: Myopia; Orthokeratology

Summary: this is a 24-month longitudinal randomized controlled trial aiming to evaluate the effectiveness of myopia control by breath-o correct orthokeratology lenses in different myopia progression groups classified according to their initial electro-retinal responses.

myopia is the most common refractive error in the world. in hong kong, the number of children in myopia is on the rise and approximately 80% of children are myopic by the end of childhood. orthokeratology is one of the most successful myopia control methods adopting the strategy of peripheral defocus, in which the natural emmetropization process is harnessed by the myopic defocus induced by the orthokeratology lenses.currently, breath-o correct lenses are new designed ready-made orthokeratology lenses which are made of new material with higher elasticity as compared traditional lens material. a recent study has shown young children with an initial weakened central electrical signal from the inner retina had faster myopia progression as measured by multifocal electroretinogram(erg). we will classify the slow and fast progression group based on the erg results, so as to evaluate the clinical effectiveness of the newly designed lenses in controlling myopia in children with different rates of progression.

Eligibility criteria:
inclusion criteria: * refractive error: spherical: -1.00d to -4.00d; cylindrical: half of sph (against-the-rule astig.: less than -0.75d) * best corrected visual acuity: monocular etdrs 0.1 or better exclusion criteria: * ocular abnormality * contra-indicated for overnight orthokeratology lens wear * history of refractive surgery * systemic diseases * history of orthokeratology lenses wearing or other myopia control methods

Keywords: myopia myopia control orthokeratology electroretinogram multifocal electroretinogram
internet-based intervention for enhancing the psychological well-being of elderly caregivers

Conditions: Depressive Symptoms; Psychological Distress; Quality of Life

Summary: this study will examine whether an internet-based acceptance and commitment therapy (act) intervention is effective, firstly, on reducing depressive symptoms, and, secondly, on improving well-being of elderly family caregivers. in our study, we will compare 1) the experimental internet-based act group to 2) standardized institutional rehabilitation carried out in rehabilitation centers and to 3) support provided by voluntary family caregiver associations

it is well-known that stress, low quality of life and depression are relatively common problems among family caregivers. the proportion of elderly family caregivers is rapidly increasing which emphasizes the need for new support systems. internet-delivered psychological interventions are one possible approach, offering benefits as they are more easily to achieve for family caregivers who often are home-bound with their relatives. this study will examine whether an internet-based acceptance and commitment therapy intervention would be effective, firstly, on reducing depressive symptoms, and, secondly, on improving well-being of elderly family caregivers.the family caregivers' depressive symptoms, perceived burden, anxiety, quality of life, psychological flexibility, personality and physical performance will be studied by a quasi-experimental study design comparing three groups of family caregivers (group 1, experimental: internet-based act intervention; group 2, active comparator: standardized institutional rehabilitation in a rehabilitation center; group 3, other: support given by voluntary family caregiver associations). data collection will be performed at three time points: pre, 4 months and post (10 months). secondly, we also aim to examine demographics and psychological variables that could predict change in depression and perceived burden over time (pre, 4 months and post (10 months). a further aim of the study is to examine potential mediators on the effect of the interventions including psychological flexibility and suppression of thoughts. moreover, we aim to study user experiences and satisfaction of the internet-based program, i.e., how the family caregivers experience and accept the web-based act intervention.

Eligibility criteria:
inclusion criteria for all groups: * family caregiver * at least 60 years of age inclusion criteria for the experimental and active comparator group - depressive symptoms and/or psychological distress exclusion criteria for all groups: * parallel psychological treatment * severe mental disorder additional inclusion criteria for the experimental group: - computer and internet connection or willingness to use a tablet provided by the study

Keywords: family caregivers depressive symptoms psychological wellbeing internet-based intervention acceptance and commitment therapy
pepsinogen-1 serum levels in hyperemesis gravidarum

Conditions: Hyperemesis Gravidarum; Pregnant With Complication

Summary: in this study, the investigators planned to investigate maternal serum pepsinogen-1 (mspg-1) levels in pregnant women with severe hyperemesis gravidarum (hg) and pregnant women without severe hg. hg is the most common cause of hospitalization in the first trimester of pregnancy and represents an economic burden on the healthcare system. therefore, our aim in this study was to investigate whether there is a statistical difference in mspg-1 levels between pregnant women with severe hg and pregnant women without severe hg and to determine a cut-off value for mspg-1 levels for the indication of hospitalization of pregnant women with hg. the study poses no risk to the pregnant woman or the fetus.

the study will enroll pregnant women in the first trimester with maternal age between 21 and 35 years who were diagnosed with hyperemesis gravidarum and had no fetal congenital or chromosomal abnormalities and who were admitted to the perinatology outpatient clinic of etlik city hospital. the investigators will include 40 cases with no signs and diagnosis of systemic maternal disease and no chronic drug use as a case group and 40 healthy pregnant women matched for age, gestational week and body mass index as a control group.

Eligibility criteria:
inclusion criteria: * a singleton pregnancy * between 21 and 35 years old * diagnosis of hyperemesis gravidarum exclusion criteria: * multiple pregnancy * fetal congenital and chromosomal abnormalities * chronic drug use, alcohol and smoking * pregnant women with diabetes or obesity, peptic ulcer or gastritis, liver and/or gallbladder disease (cholangitis or gallstones), thyroid dysfunction, urinary tract infection, celiac disease, cardiovascular or renal disease

Keywords: pepsinogen hyperemesis pregnancy
creative writing for type 2 diabetes management

Conditions: Diabetes

Summary: this study is related to the development of a new model of group care for patients with diabetes - the crewd program, incorporating close reading and creative writing in group education. a randomized trial was designed to evaluate this intervention.

a structured educational model for type 2 diabetic patients using group care is currently being used in several institutions for help managing diabetes in these patients. in this study, this model was adjusted by introducing literary texts and using narrative skills. a randomized trial was designed to determine whether group dynamic strategies using narrative and reading produce the same positive outcomes as a conventional group approach. a total of 49 patients with type 2 diabetes were randomized to two different group care dynamics, one "control group", with a classical structured educational approach and another, "intervention group", with close reading and creative writing. evaluation included anthropometrical measures, a1c and questionnaires for psychological evaluation.

Eligibility criteria:
inclusion criteria: * only patients with type 2 diabetes of \>1 year known duration, aged \< 85 years were included in the intervention. exclusion criteria: * patients that did not complete the four assessments.

Keywords: type ii diabetes educational methods disease self-management
glucocorticoids and pulmonary hypertension

Conditions: Pulmonary Hypertension Due to Lung Diseases and Hypoxia; Pulmonary Hypertension; Bronchopulmonary Dysplasia

Summary: pediatric idiopathic pulmonary hypertension has significant morbidity and mortality. an ever expanding body of knowledge indicates the important contribution of inflammation to pathogenesis and successful treatment with glucocorticoids. over the last several years the investigators have utilized steroids in patients with severe pulmonary hypertension as part of a treatment regimen. these basic science studies possibly identifies a biochemical etiology for the development of disease and may also be impacted by the administration of steroids. additionally, there is a commercially available assay which tests for all of the above molecules.


Eligibility criteria:
inclusion criteria: * premature, bpd, \>36 wga * pulmonary hypertension evidence by echocardiogram exclusion criteria: * poor ventilation/oxygenation
continuation of aspirin before isolated heart valve surgery

Conditions: Isolated Heart Valve Surgery

Summary: whether or not continuing aspirin up to de day before surgery increases the risk of bleeding and/or prevents thrombo-embolic complications remains debated. the investigators retrospectively investigated the whether continuing aspirine within 5 days of isolated heart valve surgery increased the risk of bleeding.


Eligibility criteria:
inclusion criteria: * isolated heart valve surgery exclusion criteria: * antiplatelet agent other than aspirin or anticoagulant not discontinued preoperatively * emergent or salvage surgery * surgery for endocarditis * use of nsaids within 48 hours before surgery
proud study - preventing opioid use disorders

Conditions: Anesthesia; Opioid Use

Summary: the objective of this study is to pilot an opioid free anesthetic protocol for patients undergoing total hip replacement.

the objective of this study is to pilot an opioid free anesthetic protocol for patients undergoing total hip replacement. the study team identified alternative pharmacologic methods to block pain pathways to reduce or even eliminate the need for opioids in the intra- and postoperative periods, with the goal of decreasing or eliminating exposure to opioids. a secondary objective is to assess two core competencies for interprofessional collaborative practice (interprofessional communication and teams; and teamwork) within the interprofessional care team implementing the opioid free protocol.

Eligibility criteria:
inclusion criteria intervention group: * prospective study participants undergoing unilateral total hip replacement surgery between the months of february through may, 2021 inclusion criteria control: * retrospective controls selected from the emory healthcare system clinical data warehouse that underwent unilateral total hip replacement surgery between the months of february through may, 2020 inclusion criteria professional staff: * all staff that participate in the implementation of the opioid free surgical protocol. exclusion criteria: * participants that do not speak english will not be eligible for participation in the study. * individuals less than 18 years of age will not be included for participation in the study. * individuals with cognitive impairment or the inability to provide informed consent will not be included in the study.

Keywords: hip replacement opioid free perioperative period team work
pain prevalence and risk factors among sarcoma/melanoma oncology patients in an outpatients setting

Conditions: Sarcoma; Melanoma

Summary: the primary objective of this research project is to estimate the number of patients with sarcoma or melanoma attending an outpatients clinic that are in pain or have unmet pain needs.


Eligibility criteria:
inclusion criteria: * diagnosis of sarcoma or melanoma cancer * able to respond to an assessment in written english. * able to provide informed consent to participate in the study. exclusion criteria: * patients whose health would be compromised by participation in the study
pazufloxacin mesilate ear drops clinical trial protocol

Conditions: Otitis Media

Summary: to investigate the safety, tolerance, dynamic percolation model of single dose usage pazufloxacin mesilate ear drops for patients with acute suppurative otitis media or chronic suppurative otitis media


Eligibility criteria:
inclusion criteria: 1. aged 18-65 years old, both gender; 2. patients with acute or chronic suppurative otitis media, need to be treated partially by antimicrobial agents; 3. written informed consent form. exclusion criteria: 1. allergic to quinolones antibiotics or severe allergic constitution; 2. not able to collect otorrhea during the trial; 3. high severity with the need of combined antibiotics treatment; 4. induced by pathogens, e.g.: fungus, virus (myringitis bullosa); 5. combined otitis externa (e.g.: ear cellulitis, mumps), intracranial or extracranial complication (meningitis, cerebral abscess, thrombophlebitis of sigmoid sinus, bezold's abscess, ear subperiosteal abscess); 6. severe disease of cerebral, cardiopulmonary, renal hepatic, circulatory system; 7. life-threatening disease, e.g.: malignant tumor or aids. 8. renal hepatic dysfunction (alt, ast ≥ 1.5 times of normal maximum level, cr \> normal maximum level); 9. confirmed or suspected of alcohol/drug abuse record; 10. neurological or psychiatric disease leading to inability of cooperation or not willing to follow the protocol or instruction; 11. feminine patients who are in gestational, lactation period or having a birth plan in short-term; 12. enrolled into other clinical trial in the past 3 months; 13. not suitable for this trial according to investigator's judgment;

Keywords: safety and bioavailability
endothelial function and cardiac output in rv pacing

Conditions: Bradycardia

Summary: pacing from the right ventricle (as is current practice in patients implanted with permanent pacemakers for bradycardia), has been associated with worse outcomes particularly in heart failure patients. recent clinical trials suggest that chronic right ventricular pacing (vp) is associated with worsening heart failure, increased strokes and atrial fibrillation. hemodynamically, right vp results in delayed activation and contraction of the lv which can give rise to functional mitral regurgitation, shortened diastolic filling time and thus reduced coronary filling, as well as abnormal arterial pulsatile flow. the mechanisms for the deleterious effects of right vp in heart failure patients have not been previously investigated. our aim of this study is therefore to investigate the hemodynamic effects of right vp in stable heart failure patients in terms of exercise cardiac output (co, an important measure of myocardial function and prognosis), as well as endothelial function which may be deranged as a result of abnormal arterial pulsatile flow.

study aims the aim of this study is to investigate the effect of right ventricular pacing on co at rest and exercise, and on endothelial function and b-type natriuretic peptide, bnp, in patients with heart failure. methods: thirty patients with dual chamber pacemakers for sinus node disease will be recruited: 15 controls with normal lv function and 15 with stable impaired lv function (ejection fraction \<40%). the pacemaker will be programmed to pace to back-up pacing at 55bpm in the atrial only (aai, no right vp) for one week (baseline); and than programmed to overdrive pacing at 70-80bpm, randomised to either to dual chamber, ddd (sequential atrial and ventricular pacing) with a short av delay (to ensure maximal right vp) or aai (no rv pacing), for 1 week. there will be a crossover after a 1 week washout at backup aai pacing at 55 bpm. resting and exercise co will be measured at the end of each pacing mode intervention using the inocor system (a validated non invasive method of co measurement, using inhaled inert gas equilibriums). endothelial function will be measured non-invasively at the same time points, as will plasma bnp, a measure of lv strain. patients with unstable heart failure or angina will be excluded. study endpoints: rest and exercise co; and endothelial function and bnp with and without rv pacing, in patients with preserved and impaired lv function.

Eligibility criteria:
inclusion criteria: * dual chamber pacemaker * intact av node function exclusion criteria: * unstable angina, heart failure * inability to exercise

Keywords: right ventricular pacing endothelial function cardiac output
superficial dry needling for cervicogenic headache

Conditions: Headache

Summary: it is unknown if applying superficial dry needling to the trigeminal innervation field improves pain and disability for patients with cervicogenic headaches. the aim of this study is to determine if superficial dry needling of the trigeminal innervation field improves pain, neck mobility, and disability in patients with cervicogenic headaches. it will also be examined if psychosocial factors such as stress, anxiety, depression and self efficacy influence improvements in pain, range of motion and neck disability.

cervicogenic headache (cgh), is defined by the international classification of headache disorders (ichd) as a "headache caused by a disorder of the cervical spine and its component bony, disc, and/or soft tissue elements, usually but not invariably accompanied by neck pain. prevalence of cgh in the general population is between .4-20%. although the primary source of pain is generated from the upper cervical spinal levels, there is also neuro-anatomical basis of cgh involving the trigeminal nerve. dry needling (dn) is a widely used intervention performed by physical therapists for a wide range of musculoskeletal and neurological conditions. dry needling has been shown to be beneficial for cgh but dn has only been investigated using trigger point dn to cervical musculature. superficial dn also reduces pain associated to orthopedic spinal conditions and may be associated with a lower risk of post-treatment soreness. non-thrust mobilizations of the cervical spine are an accepted treatment known to reduce pain and disability associated with cgh. their use has also been recommended in clinical practice guidelines. this study aims to look investigate whether superficial dry needling targeting the trigeminal innervation sensory field will reduce pain and impairments known to exist in patients with cgh compared to mobilizations of the cervical spine. mobilizations of the cervical spine are another common treatment that physical therapists employ to treat cervicogenic headaches.

Eligibility criteria:
inclusion criteria: * aged 18 or older * symptoms: (1)unilateral pain starting in the neck and radiating to the frontotemporal region or posterior fossa, (2) pain aggravated by neck movement, (3) restricted cervical range of motion, (4) non-throbbing and non-lancinatingnpain, 5) dysfunction/headache pain in at least one of the joints of the upper cervical spine(c0-c4), and (6) headache frequency of at least 1 per week over a period greater than 3 months. exclusion criteria: * headache or neck pain \<2/10 * contraindications to the interventions * whiplash associated disorder within 6 weeks * pending litigation for neck pain and/or headache. * unwilling to cease other care through duration of study
osteochondritis dissecans of knee prospective cohort

Conditions: Osteochondritis Dissecans

Summary: the cohort is a multi-site prospective data collection study that will enroll any patient with diagnosis of knee ocd (confirmed by a standard of care x-ray or mri). patients will be followed for up to the next 50 years of their lives to study courses of care, disease progression, treatment/surgical options/results, and specific sports-related outcomes in athletic patients. subjects will complete quality of life surveys as part of the cohort. course of care will not be affected.

patients will be recruited and consented at the visit in which their eligibility is determined. once a patient is eligible and provides informed consent, he or she will be in the study for up to 50 years, or until his or her ocd lesion is healed successfully. at the initial visit, a subject will complete a basic medical history form, and three questionnaires: the ikdc subjective questionnaire (ages over 18) or the pedi-ikdc subjective questionnaire (ages under 18); the koos questionnaire; and the marx activity scale (adult) or pedi-fabs scale (pediatric). patients will then continue with their normal course of care as determined by their surgeon and care team. mandatory surveys (same as above) will be collected from patients at 2 years, 5 years, 10 years, and 25 years. patients who cannot return to clinic will have the option to complete the assessments and return in pre-stamped and addressed return envelopes provided by the clinical site the subject is a patient at. any other follow-up visits between these time intervals will also be options for patients to complete these assessments, however patients will not complete them any closer than intervals 12 weeks apart in order to prevent redundancy. additionally, at the initial visit, the surgeon will complete a routine patient history and physical exam, which will be collected. any surgical procedures or physical therapy a patient undergoes for treatment of his or her ocd lesion will also be documented and collected. at follow-up visits, surgeons will complete their own physical exam follow-up assessment forms, which will be collected.

Eligibility criteria:
inclusion criteria: * diagnosis of osteochondritis dissecans or focal articular cartilage defects as confirmed by x-ray or mri exclusion criteria: * non-confirmed diagnosis (i.e. patient does not yet have imaging confirmation)